Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.

Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life

Drug: Ibuprofen

Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life

Placebo Comparator: Large ductus placebo

Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life

Drug: Placebo

Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life

Eligibility

Ages Eligible for Study:

up to 28 Weeks

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Gestational less than 28 weeks

Postnatal age less than 12 hours

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630278